The purpose of Core D is to provide an infrastructure of regulatory and technical expertise to maintain and manage consistent compliance with the regulatory requirements for all projects in the PREVENT Program. The Core includes two separate but complementary components: (i) oversight of the preclinical work required to support a successful IND, including interactions with the FDA and (ii) management and oversight of regulatory compliance, training, and implementation of a pre-Phase 1 clinical trial. The Core will manage, track, develop, and provide coordinated responses to all regulatory submissions and Agency interactions. This will include the transition from pre-GMP to cGMP drug substance and drug product manufacture, pilot and GLP preclinical toxicology, strategic interactions with external regulatory agencies, and IND development and submissions, with a focus on regulatory training and education and the goal of standardizing the Program's regulatory practices. The Core will also provide an overall Quality Management Plan, and implement and monitor quality control and quality assurance activities, as needed, throughout all program projects and cores. The Core will coordinate and direct all required self-monitoring activities and will serve as a central document control repository.
PREVENT Program Regulatory Affairs Core (Core D) will ensure that the overall PREVENT program complies with regulatory requirements. The core will oversee activities relating to product manufacture regulations, as well as clinical trial regulations.
Alam, Aatif; Jiang, Linda; Kittleson, Gregory A et al. (2018) Technoeconomic Modeling of Plant-Based Griffithsin Manufacturing. Front Bioeng Biotechnol 6:102 |
Kim, Bo Min; Lotter-Stark, Hester Catharina Therese; Rybicki, Edward P et al. (2018) Characterization of the hypersensitive response-like cell death phenomenon induced by targeting antiviral lectin griffithsin to the secretory pathway. Plant Biotechnol J 16:1811-1821 |
Grooms, Tiffany N; Vuong, Hung R; Tyo, Kevin M et al. (2016) Griffithsin-Modified Electrospun Fibers as a Delivery Scaffold To Prevent HIV Infection. Antimicrob Agents Chemother 60:6518-6531 |
Barton, Christopher; Kouokam, J Calvin; Hurst, Harrell et al. (2016) Pharmacokinetics of the Antiviral Lectin Griffithsin Administered by Different Routes Indicates Multiple Potential Uses. Viruses 8: |
Fuqua, Joshua L; Wanga, Valentine; Palmer, Kenneth E (2015) Improving the large scale purification of the HIV microbicide, griffithsin. BMC Biotechnol 15:12 |
Fuqua, Joshua L; Hamorsky, Krystal; Khalsa, Guruatma et al. (2015) Bulk production of the antiviral lectin griffithsin. Plant Biotechnol J 13:1160-8 |